In a major escalation of the global race to treat neurodegenerative disease, healthcare major iRegene Therapeutics has crossed two critical clinical milestones on opposite sides of the world — dosing its first US Phase IIa Parkinson’s patient and enrolling the first participant in China in a randomized Multiple System Atrophy (MSA) trial.

 

The dual advances push the company’s experimental, off-the-shelf cell therapies into mid-stage testing, marking a pivotal shift from early safety validation to rigorous efficacy evaluation across international patient populations.

 

At Weill Cornell Medical Center, the first US patient has been dosed with NouvNeu001, an investigational induced pluripotent stem cell (iPSC)-derived therapy chemically programmed into dopaminergic progenitor cells. The treatment was delivered via stereotactic neurosurgery into the bilateral putamen as part of an open-label Phase II study.

 

The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration, which cleared the therapy for direct Phase II entry in the third quarter of 2025 after granting both Fast Track and Regenerative Medicine Advanced Therapy designations.

 

NouvNeu001 is engineered to replace dopamine-producing neurons lost in Parkinson’s disease and potentially alter disease progression — a “single dose, sustained benefit” strategy aimed at a condition that remains incurable. Parallel Phase II trials are now underway in both the US and China.

 

At the same time, iRegene enrolled the first patient in China in a randomized controlled trial of NouvNeu004 for MSA at Beijing Tiantan Hospital, under Principal Investigator Professor Yilong Wang. 

 

"Dosing the first U.S. patient for Parkinson's disease and enrolling the first MSA patient in China are pivotal milestones in our mission to deliver transformative, disease-modifying therapies to patients worldwide," said Dr Meng Cai, Chief Medical Officer of iRegene Therapeutics.

 

"These parallel advances reflect the productivity of our 'AI + Chemical Induction' platform, yielding two pioneering 'off-the-shelf' cell therapies: NouvNeu001 for Parkinson's disease and NouvNeu004 for Multiple System Atrophy. Together, they demonstrate our commitment to a robust global development pathway and our continued contribution to the advancement of cell therapy for neurodegenerative diseases."